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临床试验/NCT04884698
NCT04884698已完成不适用

"Electromagnetical Stimulation of the Phrenic Nerve to Generate Contraction of the Diaphragm in Healthy Subjects and Anaesthetized and Intubated Patients - a Feasibility Study"

Stimit AG1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年6月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
1
主要终点
Change in airway pressure / endpoint Group 2:

研究概览

简要总结

The scientific study is intended to show that external non-invasive electromagnetic stimulation can be used to safely and effectively stimulate the phrenic nerve in awake healthy subjects as well as in ventilated, anesthetized patients and that the stimulation can generate a diaphragmatic contraction that generates significant breath volume - a Controlled Own Breath (COB).

Also of interest is the reproducibility of the generated diaphragmatic movements and the reliability of different feedback signals for detecting the generated diaphragmatic contraction. This applies to inspiration and expiration detection for subsequent synchronization mechanisms of the magnetic stimulator for patient-initiated breathing as well as to contraction intensity. Further, the characterization of the position finding process is of great importance, so that technical developments can further simplify the process of coil positioning in the future. The possible occurrence of discomfort and pain sensation will also be investigated in awake healthy volunteers. Different stimulation protocols will be used.

Finally, it will be investigated whether an adjusted coil position still triggers reproducible diaphragmatic contractions after removal and repositioning in the same configuration. The knowledge gained will be used to further develop the technique and to prepare a study in critically ill, ventilated patients where the diaphragmatic muscle is to be treated preventively by stimulating the phrenic nerve, in order to prevent atrophy of the muscle.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Persons aged > 18 years
  • Applicable for Group 2: planned for elective surgery
  • No relevant pre-existing conditions - corresponding to American Society of Anesthesiologists (ASA) level of I-II.
  • Written informed consent by the patient for participation in the study given

排除标准

  • chronic lung diseases (bronchial asthma, COPD)
  • known diaphragmatic weakness
  • known neurological conditions with motor muscle weakness
  • known paralysis of the phrenic nerve
  • conditions that limit the mobility of the diaphragm (high intra-abdominal pressure, ascites, BMI >30)
  • not able to read and understand the national language German
  • skin lesions, infections or strictures in the neck area
  • persons with Implanted cardiac support systems (pacemaker, implanted defibrillator)
  • persons with implanted medical pumps
  • pregnant women
  • persons deprived of liberty by administrative or judicial decision or under legal guardianship.
  • Participation in another clinical trial
  • Applicable for group 2 (intubated and mechanically ventilated) patients: Exclusion criteria at the time of stimulation:
  • Unstable patient after induction of anesthesia and intubation

结局指标

主要结局

Change in airway pressure / endpoint Group 2:

时间窗: During stimulation

The primary outcome / endpoint is the change in airway pressure during stimulation as seen with or without the use of the ventilator during stimulation.

Change in airway pressure / endpoint Group 1:

时间窗: During stimulation

The primary outcome / endpoint is the change in airway pressure at the mouth during stimulation as seen with or without the use of the ventilator

Discomfort / pain during stimulation measured by Visual Analogue Scale / endpoint Group 1:

时间窗: During stimulation

The primary outcome / endpoint is the level of discomfort / pain during stimulation, measured by Visual Analogue Scale(0-100, with 100 being worst pain / discomfort)

次要结局

  • Optimal stimulation site - distance(During stimulation)
  • Skin reactions / musle activation(During stimulation)
  • Safety outcome(During stimulation and postoperatively, usually within 2-3 hours)
  • Tidal volumes(During stimulation)
  • Diaphragmatic contraction(During stimulation)
  • Feedback signals(During stimulation)
  • Time stimulation start to end(During stimulation)
  • Optimal stimulation site - time(During stimulation)
  • Correlation stimulation intensity and diaphragm contraction(During stimulation)

研究者

发起方
Stimit AG
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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